Medtronic to Update Device Label After Spinal Surgery Deaths

Deborah Brauser

Disclosures

May 03, 2017

Medtronic has notified the US Food and Drug Administration (FDA) of plans to update labeling on its NavLock Tracker device following numerous reports of patient injuries that include two deaths, according to an FDA MedWatch alert sent out today.

The company, which issued a communication letter about the Tracker on May 1, notes that because the adverse events are associated with using the device with non-Medtronic instruments during surgical procedures, it will be including a warning against this practice.

"The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system [and] should only be used with Medtronic instruments," part of the new label will read.  

The use of other types of instruments with the Tracker device "may result in inaccuracy, leading to serious injury or death," it adds.

The FDA identified 196 related medical device reports (MDRs) between January 2013 and March 22, 2017. Spinal injury due to misplaced or misaligned screws made up the majority of the reported injuries.

Interestingly, although use of third-party surgical stereotaxic navigation instruments was referenced in the MDRs, the limited availability of data makes it "unclear if, and to what degree, the use of [those] instruments caused or contributed to the adverse event," according to the MedWatch alert.

"Additionally, the FDA recognizes that the contributing factors associated with accuracy and precision problems when using stereotaxic navigation systems are multifactorial," it states.

The two patients who died had postoperative hemorrhage after undergoing spinal procedures that involved third-party navigation instruments not cleared for this type of use by the FDA.

No deaths have been reported in relation to procedures where the Tracker was used with Medtronic navigation instruments or with third-party instruments cleared by the FDA. Clearance for this purpose has been granted to instruments from Alphatec Spine, Globus Medical, and Orthofix.

Recommendations from the FDA expands on the manufacturer's planned labeling updates to say that clinicians should use only instruments that the Agency has cleared for use with the company's Tracker and surgical navigation system — although they add that clinicians should be made aware of the company's communication disclaimer icon about non-Medtronic instruments.

Other recommendations include the following:

  • Repeated assessments throughout the procedure to ensure surgical accuracy;

  • Reporting of any Tracker-related adverse events; and

  • Inclusion of detailed information, including brand and instrument model, if  an FDA report is submitted.

The FDA's MedWatch Safety Information and Adverse Event Reporting Program forms are located on their website, as is their full Health Provider Letter about the device.

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